Soft Gelatin Capsule Shell : Composition, Formula and

Preparation
A soft gel capsule is a one piece, hermetically sealed soft gelatin shell containing a liquid, a suspension or a semisolid; referred
to as a fill. The soft gel shell is usually comprised of a film-forming material such as gelatin, and a water-dispersible or watersoluble plasticizer (to impart flexibility). The soft gel shell could also include minor additives such as coloring agents, flavors,
sweeteners, opacifying agent, medicaments, acid and preservatives. Soft gel capsules can also be enteric coated for certain
applications.

Capsule shell composition:

Water : 45% w/w. The ratio by weight of water to dry gelatin can vary depending from 0.7-1.3 (water) to 1.0 (dry
gelatin) depending on the viscosity of the gelatin being used.
Plasticizer. Used to make the soft gel shell elastic & pliable. Ration used is between 0.3- 1.8 for soft to hard shell on
dry basis. Plasticizer usually used : Glycerin and sorbitol.

Coloring Agent. Colour used in shell has to be darker than color of encapsulating material. Color may be natural or
synthetic.

Opacifier. Usually used is titanium dioxide, may be added to produce an opaque shell, when the fill formulation is a
suspension or to prevent photo degradation of light sensitive fill ingredients. Concentration of oacifier may be up to 0.5%.

Chelating agents. Iron is always present in raw gelatin & should not contain iron more than 15 ppm. Additionally
chelating agent may be used for preventing the reaction of iron with materials or colors.

Gelatin
Soft Capsules Gelatin
Gelatin is derived mostly from collagen by thermal denaturing with the aid of diluted acid or alkali. Gelatin contains a mixture of
water-soluble proteins (84-90 percent), mineral salts (1-2 percent), and water (8-15 percent). These proteins contain a significant
amount of the amino acids: glycine, proline, hydroxyproline, glutamic acid, alanine, arginine, aspartic acid, lysine; in addition to
other amino acids in smaller amounts.
There are two types of gelatins:
1. type A : derived from pork skin by hydrolysis with an acid
2. type B : derived from bones and animal skin by hydrolysis with an alkaline solution.
Gelatin used in soft gels is a blend of both types, or used individually.
Gelatin is odorless, tasteless, colorless, and insoluble in most organic solvents, but soluble in glycerin, diluted acids and alkalis.
Gelatin swells and absorbs room-temperature water, up to five to 10 times its weight. It dissolves in hot water, and forms a gel
upon cooling.
The main source of gelatin is collagen, which is found in the skin and bones of animals such as deep-water fish. Most of the soft
gel capsules on the market are made from an animal source, bovine or porcine.
There are non-animal based forms of gelatin to meet the needs of those wishing alternatives to meat products for vegetarian,
ethical or religious reasons. A vegetarian gelatin made from Irish moss, which is derived from seaweed and grows off the coast of
Ireland, is available but is costlier than the animal-sourced gelatins. The brand name called Vegicap soft capsule.
Typical Formula of Soft Gelatin Capsule Shell for 1 batch = 120 L

Ingredients/Materials
Glycerin

Amount(kg)
52

Function
Plasticizer

Propylmethyl Paraben

0.512

Preservative

Methyl Parabe

0.128

Preservative

Gelatin 120 Bloom

152

Basisofgelatin

Briliant Blue Ponceau

0.3

Coloringagent

Sunset Yellow

0.3

Coloringagent

Titanium Dioxide

16

Opacifier

Water
Sorbitol Liquid

120L
16

Solvent
Plasticizer

Preparation of Soft Gelation Capsule Solution:

The gel is prepared in a 100 liter stainless steel vessel:
1.
Gelatin Powder is mixed with water and glycerin, then heat and stir it.
2.
After the molten gelatin mass is formed, decanted into 200 kg mobile vessels.
3.
Mix the molten gelatin mass using turbine mixer then add color and flavors agent.
4.
It ensure consistency of gelatin mass
5.
This mass is kept at a constant temperature until it is needed for the next stage of the process